Negative pressure wound treatment system and method

ABSTRACT

A negative pressure wound treatment system comprising a bandage portion and a negative pressure portion. The bandage portion includes a dressing portion in contact with a wound and a sealing layer positioned in contact with the dressing portion. The sealing layer includes an adhesive creating a seal around the wound. The negative pressure portion is in fluid communication with the bandage portion and includes a first valve and a second valve. The first valve is in fluid communication with the bandage portion and the negative pressure portion. The second valve is in fluid communication with the negative pressure portion and the surrounding environment. The negative pressure wound treatment system is configured to provide negative pressure to an area sealed by the bandage portion upon the actuation of the negative pressure portion. The negative pressure portion is configured to be actuated by compressing the negative pressure portion while walking.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/761,659 filed Mar. 20, 2018, which represents the national stageentry of PCT International Application PCT/US2016/052817 filed Sep. 21,2016, which claims benefit of U.S. Provisional Application 62/221,342filed Sep. 21, 2015, all of which are incorporated herein in itsentirety by reference

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not applicable

SEQUENCE LISTING

Not applicable

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure generally relates to a wound treatment system andmethod, and more specifically, to a negative pressure wound treatmentsystem and method for treating wounds with negative pressure generatedby a user walking while wearing a device.

Description of the Background of the Invention

Negative pressure wound therapy (NPWT) is a treatment that aids in thehealing of wound injuries by increasing blood flow to the target areaand promoting the formation of granulation tissue. It also functions inremoving and draining fluid and leakage, diminishing both the amount andrate of infection and bacterial growth, assisting in closure, andproviding protection from the surrounding environment. Such a devicetypically is comprised of: 1) a gauze or wound dressing to fill thecavity, 2) a drainage tube held near the area of injury, sometimesinside of the dressing, 3) an adhesive sealant placed atop the dressingto create an air tight seal, 4) a container or outlet for the fluiddrained from the injured area, and 5) a low-pressure vacuum to createnegative pressure. The dressing of the wound requires frequentreplacement. According to the Food and Drug Administration, NPWT isproven to provide aid to chronic wounds, burns, diabetic and pressureulcers, acute wounds, traumatic wounds and dehisced wounds. In additionnegative pressure can locally induce or mimic the therapeutic effects ofmassage.

A special case of wounds are diabetic foot ulcers (DFUs). DFUs are aleading cause of lower limb amputations. Diabetes affects hundreds ofmillions of people worldwide, including tens of millions of patients inUS, and are projected to double by 2030. DFUs are a primary cause ofhospital admissions in the developed world and one of the most impairedconditions associated with diabetes, often leading to pain, suffering,and a poor quality of life for patients. DFUs precede a significantmajority of all diabetes-related lower-leg amputations and arecharacterized by impaired healing.

Portable NPWT devices have been proposed in the art, however manyrequire an external power supply for creating negative or positive airpressure. Another disadvantage of the devices described in the art isthat patients cannot wear them for natural walking. Some of the priorart devices that can be worn while walking require the entire foot andlower leg to be sealed and covered, resulting in comfort issues. Furtherstill, other devices in the prior art require a hand powered device thatis to be used at developing areas, but the operation requires activepatient activity and attention.

Therefore, there is a need for a NPWT system that overcomes one or moreof the aforementioned drawbacks of NPWT devices known in the art. Inparticular, there is a need for a NPWT system and method that generateslow pressure by introducing means under a foot of the user configured tobe actuated by walking and the area treated is specific to an areaslightly larger than one or more DFU's positioned on a lower extremityof the user.

SUMMARY OF THE INVENTION

A negative pressure wound treatment system includes a bandage portionand a negative pressure portion. The bandage portion includes a dressingportion in contact with a wound and a sealing layer positioned incontact with the dressing portion. The sealing layer creates a sealaround the wound. The negative pressure portion is in fluidcommunication with the bandage portion and includes a first valve and asecond valve. The first valve is in fluid communication with the bandageportion and the negative pressure portion. The second valve is in fluidcommunication with the negative pressure portion and the surroundingenvironment. The negative pressure wound treatment system is configuredto provide negative pressure to an area sealed by the bandage portionupon the actuation of the negative pressure portion. The negativepressure portion is configured to be actuated by compressing thenegative pressure portion while walking. The sealing layer may includean adhesive creating the seal around the wound.

According to another aspect of the negative pressure wound treatmentsystem, the bandage portion and the negative pressure portion areconfigured as an innersole device that is positioned within a shoe ofthe user.

According to another aspect of the negative pressure wound treatmentsystem, the bandage portion is sized to seal an area that issubstantially the entire bottom of a user's foot.

According to another aspect of the negative pressure wound treatmentsystem, the negative pressure portion comprises a collapsible hollowbulb.

According to another aspect of the negative pressure wound treatmentsystem, the dressing portion comprises at least one of gauze, porousfoam, and a therapeutic scaffold.

According to another aspect of the negative pressure wound treatmentsystem, the bandage portion is sized to seal a portion of the bottom ofa user's foot surrounding the wound and the negative pressure portion ispositioned under an adjacent portion of the user's foot.

According to another aspect of the negative pressure wound treatmentsystem, the bandage portion is positionable to seal an area located on alower extremity of a user and the negative pressure portion ispositionable below the user's foot.

According to another aspect of the negative pressure wound treatmentsystem, the system includes at least one sensor.

According to another aspect of the negative pressure wound treatmentsystem, the sensor is at least one of a pedometer and a pressure sensor.

According to another aspect of the negative pressure wound treatmentsystem, the information collected by the sensor is at least one ofrecorded and broadcasted to an external device.

According to another aspect of the negative pressure wound treatmentsystem, the valve includes a release mechanism, trigger or switch.

A wound healing device includes a first chamber and a second chamber.The first chamber includes a dressing and is configured to form a sealaround a wound of a user. The dressing is in contact with the wound. Theseal is around the perimeter of the first chamber. The second chamberincludes at least one valve. The second chamber is in fluidcommunication with the first chamber through the at least one valve.Actuation of the second chamber creates a negative pressure environmentin the first chamber. The second chamber is configured and positioned tobe actuated by a user while walking. The seal may be formed by anadhesive around the perimeter of the first chamber.

According to another aspect of the wound healing device, the firstchamber collects liquid from the wound.

According to another aspect of the wound healing device, the secondchamber includes a reservoir configured to collect liquid from thewound.

According to another aspect of the wound healing device, the reservoircomprises an absorbent material.

According to another aspect of the wound healing device, the firstchamber includes a reservoir configured to collect fluid from the wound.

According to another aspect of the wound healing device, the firstchamber includes a reservoir configured to collect fluid from the woundand the reservoir comprises an absorbent material.

According to another aspect of the wound healing device, the secondchamber is in fluid communication with the first chamber through the atleast one valve, and the second chamber is in fluid communication withthe surrounding environment through a second valve.

According to another aspect of the wound healing device, the at leastone valve and the second valve are one-way valves.

According to another aspect of the wound healing device, the firstchamber and the second chamber are configured as part of a shoe insoleand the second chamber is configured to form a seal around a portion ofa bottom of the user's foot and the portion includes the wound.

According to another aspect of the wound healing device, the firstchamber is configured to form a seal around a wound on a portion of auser's lower extremity away from a bottom of the user's foot and thesecond chamber is configured to be position under a user's foot within ashoe.

According to another aspect of the wound healing device, the firstchamber and the second chamber are connected via a flexible tube.

According to another aspect of the wound healing device, the secondchamber is part of a shoe insole.

According to another aspect of the wound healing device, wherein any ofthe valves include a release mechanism, trigger or switch.

A method of treating a wound on a lower body extremity with negativepressure wound therapy includes the following steps. A first chamber ispositioned over a wound on the lower body extremity and the firstchamber includes a dressing configured to contact the wound. A seal isformed around the perimeter of the first chamber. A second chamber ispositioned below the lower body extremity and the second chamber isconfigured to be actuated by the lower body extremity during walking.The first chamber is fluidly coupled to the second chamber through afirst valve. The second chamber is fluidly coupled to the surroundingenvironment through a second valve. Actuation of the second chambercauses a negative pressure environment to be formed within the firstchamber over the wound. The seal may be formed around the perimeter ofthe first chamber with an adhesive. However, a seal can be made withoutadhesives, for example, using a rubber or plastic piece as sealing andholding and pressing the perimeter with a bandage.

According to another aspect of the therapy, the method includes thesecond chamber positioned within a shoe and the first and secondchambers are configured as an insole device sized to fit with the shoe.

According to another aspect of the therapy, the method includes thesecond chamber positioned within the shoe of the user and the firstchamber positioned away from the shoe of the user. The first chamber isconnected to the second chamber through a flexible tube.

According to another aspect of the therapy, the method includescollecting fluid from the wound in the first chamber, wherein the firstchamber includes an absorbent reservoir.

According to another aspect of the therapy, the method includescollecting fluid from the wound in the second chamber, wherein thesecond chamber includes an absorbent reservoir.

According to another aspect of the therapy, the method includespositioning the first chamber adjacent the second chamber and the firstchamber is configured to seal around the wound located on the bottom ofa foot of a user. The first chamber and the second chamber areconfigured as components of a self-adhesive bandage.

According to another aspect of the therapy, the method includes thenegative pressure environment formed within the first chamber is in therange from about 40 millimeters of mercury to about 200 mm of mercury.

According to another aspect of the therapy, the method includes that anyof the valves include a release mechanism, trigger or switch.

According to another aspect of the wound healing device, a wound healingdevice comprises a first chamber, a second chamber and at least onevalve wherein the first chamber is in contact with a wound and thesecond chamber exchanges fluids in care of the pressure applied by thelower extremity of a subject and the valve regulates the pressurebetween any of the first chamber, the second chamber, and externalsurroundings of the wound healing device.

According to another aspect of the wound healing device, the firstchamber collects fluids from the wound.

According to a further aspect, the wound healing device includes areservoir that collects and stores fluids from the wound.

According to another aspect of the wound healing device, the reservoiris positioned within the second chamber.

According to another aspect of the wound healing device, the reservoirincludes an absorbent material.

According to another aspect of the wound healing device, the reservoiris positioned within one of the first chamber, or a duct or passagebetween the first chamber and the second chamber.

According to another aspect of the wound healing device, the devicelacks the reservoir that collects or store fluids from the wound

According to another aspect of the wound healing device, the firstchamber and the second chamber are combined into one chamber forproviding NPWT.

According to another aspect of the wound healing device, the firstchamber and the second chamber are in fluid communication through atleast one of a valve, a duct, and a flexible tube.

According to another aspect of the wound healing device, the secondchamber further includes a valve in fluid communication with thesurrounding environment.

According to another aspect of the wound healing device, the wholedevice is sized to fit within footwear of the user.

According to another aspect of the wound healing device, the firstchamber is affixed to a lower extremity of a user with a mesh outside ofthe user's footwear.

According to another aspect any of the above devices can be applied overnon wounded skin to induce therapeutic effects different from the woundhealing

These and other features, aspects, and advantages of the presentinvention will become better understood upon consideration of thefollowing detailed description, drawings and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a NPWT system;

FIG. 2 is a depiction of a first embodiment of a NPWT system accordingto the invention;

FIG. 3 is a depiction of a second embodiment of a NPWT system accordingto the invention;

FIG. 4 is a depiction of a fourth embodiment of a NPWT system accordingto the invention;

FIG. 5 is a depiction of a fifth embodiment of a NPWT system accordingto the invention;

FIG. 6 is a flow chart depicting a treatment process utilizing a NPWTsystem according to the invention; and

FIG. 7 is a flow chart depicting a treatment process utilizing a NPWTsystem including a sensor according to the invention.

Like reference numerals will be used to refer to like parts from Figureto Figure in the following description of the drawings.

DETAILED DESCRIPTION

Patients affected by chronic wounds are often bed-ridden due to thepresence of bulky dressings and equipment which impair their ability tomove and walk. This condition worsens the quality of life of thepatients as well as their ability to heal since walking has a beneficialeffect on lower limb microcirculation. A portable and wearable NPWTdevice may provide enhanced quality of life and healing benefits topatients suffering from DFU and other wounds located on the lowerextremities and other parts of the body. In the embodiments disclosedhereinafter, patients may produce the low pressure or vacuum needed forNPWT just by walking with at least a portion of the wearable NPWT deviceunder a foot. This would give patients the improved ability to maintaina healthy and improved quality of life over traditional systems.Further, no external power supply is needed and the patient's ability orcapacity to move and walk during treatment would not be limited ascompared to traditional methods. It has been show that negative pressurecan induce therapeutic effects when applied to healthy skin. It cancreate a suction effect that increases blood and lymphatic circulationsystemically and to the local area, relaxes muscle tissue and support,draws stagnation, pathogenic factors and toxins out of the body andreleases a myriad of pain causing factors. A common application of theseeffects are known from several years in techniques as cupping that caneven being combined with massage along with the movements performed andareas treated by a therapist will produce stimulating (toning) orsedating (draining) effects. Conditions as chronic venous insufficiency(CVI) or plantar fasciitis, the present invention can be employed inaddition to other physiotherapy surgery, drug treatment andsclerotherapy, with both prophylactic and curative intent. Apart fromimproving the hemodynamic situation, localized negative pressure therapyaims in particular to preserve or reactivate the active and passive pumpmechanisms of the lower limbs, for example, the calf muscle pump and theankle pump. In addition, localized negative pressure can helpdesensitize those areas affected by neurogenic pain as foot neuropathyas a complement or in replacement of traditional massage. In lymphedema,tissue fluid steadily accumulates in the subcutaneous space containingloose connective tissue. Since there is no force that could mobilize andpropel stagnant fluid to the regions where lymphatics absorb andcontract, this task should be taken over by external massage or forces.In one embodiment, negative pressure can be applied one the skin surfaceof the affected region redirecting fluids and restoring lymphaticfunction. In a similar manner some of the devices described can be usedto treat edema.

In one embodiment at least one of the valves can be activated ordeactivated by a release mechanism, trigger or switch, thus creatingdifferent cycles of presence or absence of negative pressure over theinterest area. The release mechanism, trigger or switch can be electricor mechanic and even can be activated remotely or triggered by anexternal device or timer. In a more specific embodiment, the releasemechanism, trigger or switch includes a pressure sensor that enables theapplication of negative pressure can be regulated or determined by athreshold.

Referring to FIG. 1, a schematic embodiment of a negative pressure woundtreatment system 100 according to the invention for providing negativepressure wound therapy is depicted. The treatment system 100 is showncovering a wound 102 located on a body portion 104 of a patient. Thewound 102 may be a chronic wound, a DFU, a burn or any type of woundthat one having ordinary skill in the art would understand asappropriate for NPWT. The body portion 104 may be located on the sole ofa patient's foot or any other portion of a patient's body including butnot limited to the lower extremities. As will be disclosed later,different embodiments will demonstrate treatment of wounds positionedaway from a patient's foot while walking generates the necessaryconditions for successful NPWT.

Still referring to FIG. 1, the treatment system 100 includes a firstchamber or bandage portion 106 and a second chamber or negative pressureportion 108. The first chamber 106 includes a sealing layer 110 thatforms an air-tight seal over the wound 102 and a small area around thewound. The sealing layer 110 may form the seal over the wound 102 byapplication of an adhesive 112 around the perimeter of the sealing layer110. It is contemplated that the sealing layer 110 may be a flexiblelayer of any shape that facilitates the coverage of the wound 102. Forexample, the shape and type of materials used for the sealing layer 110may be optimized depending on the location placed on the body of thepatient. In some embodiments, the sealing layer 110 may be formed from arigid or semi-rigid material that is secured by adhesive 112 around theperimeter of the sealing layer 110. Alternatively, a sealing layer 110may be attached and form a seal on the body portion 104 by other methodsinvolving adhesive 112. For example, a tape layer (not shown) may beplaced over the sealing layer 110 that extends around the sealing layer110 to form an air-tight seal over the wound 102. Further, the sealinglayer may be formed by spreading an adhesive that forms the sealinglayer 110 and thus creates the first chamber 106. One non limitingexample of adhesive can be cyanoacrylate or its derivatives. One havingordinary skill in the art would understand the various ways adhesive 112could be applied to flexible and rigid or semi-rigid materials to forman air-tight seal over a wound 102.

Continuing to refer to FIG. 1, the first chamber 106 may include adressing portion 114. The dressing portion is positioned to be incontact with the wound 102 and the sealing layer 110. It is contemplatedthat the dressing portion may comprise any number of materials orcombination of materials. Some not limiting examples would betraditional gauze and bandage materials, porous foam, and therapeutic orregenerative scaffolds. The dressing portion 114 may be any combinationof these or other materials. In some embodiments, the first chamber mayinclude a reservoir 116 for the collection of fluids from the wound 102.The reservoir 116 may include an absorbent material in contact with thedressing portion 114. Non limiting examples of absorbent materials caninclude gauze and bandage, nafion or a combination thereof. Alternativeembodiments can avoid this chamber for fluid collection, for examplewhen applied to wounds that have no significant liquid excretions.

The second chamber 108 is in fluid communication with the first chamber106 through a first valve 118. The first valve 118 may be positionedwithin the first chamber 106, within the second chamber 108, or in atube 120 that connects the first chamber 106 to the second chamber 108.In some embodiments, the tube 120 may be just a duct and the firstchamber 106 and the second chamber 108 may be in very close proximityand or contact with each other. In other embodiments, the tube 120 maybe longer allowing the first chamber 106 to be spaced a distance awayfrom the second chamber 108. It is contemplated that the distancebetween the first chamber 106 and the second chamber 108 can vary basedon the application and the location of the wound 102 to be treated. Aswill be shown in later embodiments, the first chamber 106 may be placedadjacent to the second chamber 108 or the first chamber 106 may beplaced away from the second chamber 108.

Still referring to FIG. 1, the second chamber 108 may also include areservoir 122 for the collection of fluids from the wound 102. Thereservoir 122 may be positioned within the second chamber 108 in anyorientation or location favorable for the collection of fluid. Thereservoir 122 may be formed from absorbent material placed within thesecond chamber 108. Alternatively, it is contemplated that in someembodiments a separate reservoir may be formed from a third chamber (notshown) that is positioned between the first chamber 106 and the secondchamber 108 for the purpose of collecting fluids from the wound 102. Itis also contemplated that the first chamber 106, the second chamber 108,and the third chamber (not shown) are in fluid communication with eachother. Further, in some embodiments the third chamber (not shown) mayinclude absorbent materials (not shown) disposed within the thirdchamber (not shown). The tube 120 may be divided into two sections (notshown)) connecting the third chamber (not shown) to the first chamber106 and the second chamber 108.

The second chamber 108 also includes a second valve 128 that may beplaced in a duct 130 that provides fluid communication between thesecond chamber 108 and the surrounding environment. It is alsocontemplated that the second chamber 108 is constructed of a resilientbut compressible material. As will be detailed later, the actuation(i.e., the application and removal of a compressive force) of the secondchamber creates the low pressure environment in the first chamber 106for the NPWT. It is contemplated that the actuation of the secondchamber 108 will result in a low pressure environment in the firstchamber 106 that is in the range from about 40 millimeters of mercury(mm of Hg) to about 200 mm of Hg, or in the range from about 80millimeters of mercury (mm of Hg) to about 140 mm of Hg. It iscontemplated that the low pressure created within the first chamber 106may be tuned or adjusted by the use of different second chambers 108,first valves 118, or second valves 128. The treatment system 100 mayinclude an outer cover 132. It is contemplated that the outer cover 132may take different forms in the different embodiments disclosed below.The outer cover 132 may assist in retaining the treatment system 100 orportions of the treatment system 100 in place on the patient. The outercover 132 may include adhesive for securing portions of the treatmentsystem 100 in place or may comprise a wrap that would wrap around a footor lower extremity portion of a patient.

Still referencing FIG. 1, the general operation of the treatment system100 is disclosed. The first chamber 106 is positioned over a wound 102and the dressing portion 114 is positioned in contact with the wound102. A seal is formed around the perimeter of the first chamber withadhesive 112. The second chamber 108 is positioned below a foot of thepatient. The first chamber 106 is fluidly coupled to the second chamber108 through the first valve 118. The second chamber 108 is fluidlycoupled to the surrounding environment through the second valve 128. Thepatient begins walking. As the patient steps onto the foot with thesecond chamber 108 positioned below it, a compressive force is appliedto the second chamber 108. As the second chamber 108 is compressed, airwithin is pushed out through the second valve 128. Upon the release ofthe compressive force, the resilient nature of the second chamber 108causes the second chamber 108 to revert to the original uncompressedshape and a low pressure environment is created. The low pressure in thesecond chamber 108 will then draw air and possibly fluid from the firstchamber 106 through the first valve 118 creating a lower pressureenvironment in the first chamber 106. It is contemplated that thecompression of the second chamber 108 is only partial and that severalcycles of compression may be required for the first chamber to reach thedesired low pressure range for NPWT as described above. Eventually, thepressure in the first chamber 106 will be low enough to provide thetherapeutic benefits of NPWT to the wound 102. The pressure in the firstchamber may eventually reach equilibrium with the resilient nature ofthe second chamber 108 such that the second chamber remains partiallycompressed even after the compressive force is removed. As the pressureincreases in the first chamber 106 however, the second chamber 108 maypartially uncompress and draw air and fluid from the first chamber 106thus maintaining a low pressure environment in the first chamber 106.The positioning of the second chamber 108 under the sole can varyaccording to the embodiment and use.

It is also contemplated that the first valve 118 and the second valve128 may include a release mechanism that is accessible by the user. Inthis way the user can create different cycles of the presence or absenceof negative pressure over the area of interest. It is furthercontemplated that the release mechanism may be a trigger or a switch.

It is contemplated that the duration of time that the treatment system100 may be used to treat a wound 102 depends on numerous variables. Insome embodiments, all of the components may be sized such that anyabsorbent materials within the first chamber 106 and the second chamber108 may become saturated from fluids from the wound 102 in a few hours.In some embodiments the time period may be between about 3 hours toabout 6 hours, or about 3 hours to about 12 hours, or about 3 hours toabout 24 hours. Alternatively, the time period may be extended tomultiple days depending on the size of the components and the nature andcondition of the wound.

Still referring to FIG. 1, it is contemplated that the treatment system100 may include at least one sensor 150 in communication with at leastone external device 155. The communication (represented by a line 160)between the at least one sensor 150 and the external device 155 may beby a wired or wireless process. One having ordinary skill in the artwould recognize the multitude of ways the at least one sensor 150 couldsend or transmit information to the at least one external device 155. Itis contemplated that the at least one sensor could be a wide variety ofsensor types that may provide a wide variety of useful data to thepatient and/or a healthcare provider monitoring the patient. In oneexemplary embodiment, the sensor 150 may be a pressure sensor thedetermines the pressure level achieved in the first chamber 106 whilethe patient is walking and/or not walking. In another exemplaryembodiment, the sensor 150 may include the ability to determine thenumber of times the second chamber 108 has been actuated to generatenegative pressure in the first chamber 106. Further embodiments mayinclude external devices 155 that is at least one of a pedometer, asmart phone, a smart wearable device (e.g., a watch) that is capable ofreceiving communications from the at least one sensor 150. It is furthercontemplated that the external device may be capable of at leastrecoding and or displaying the data. Some embodiments may include theexternal device 155 communicating the data received from the sensor 150to other external devices via a variety of means (e.g., a cellular dataconnection, a Wi-Fi connection, a wired internet connection, a Bluetoothconnection). It is also contemplated that the health care provider maymonitor the data transmissions from the patient in person or remotelyvia electronic transmissions. One having skill in the art wouldunderstand the multitude of ways via different communication protocolsthat the sensor 150 may communicate information to the external device155 and in turn that information is recorded for or transmitted to thehealth care provider for aid in determining the effectiveness of thetreatment.

Turning to FIG. 2, a schematic embodiment of a negative pressure woundtreatment system 200 is depicted in the form of an innersole deviceconfigured to fit inside footwear of patient. The treatment system 200includes a first chamber 206 and a second chamber 208. The first chamber206 includes a sealing layer 210 that is in the form of an innersole offootwear that a patient may wear. The perimeter of the first chamber 206forms a seal with an adhesive strip 212. In the present embodiment, thefirst chamber includes a dressing portion 214 that may contact anywounds (not shown) on the lower surface of the patient's foot. Thesecond chamber 208 is in fluid communication with the first chamber 206through a first valve 218. The second chamber 208 is also in fluidcommunication with the surrounding environment through a second valve228. It is contemplated that the embodiment depicted in FIG. 2 mayinclude all or some of the characteristics and features of the treatmentsystem 100 depicted in FIG. 1.

Still referring to FIG. 2, the treatment system 200 may be configured tocover and create a low pressure environment that is substantially theentire bottom of the foot of a patient. In some embodiments, thetreatment system 200 may be sized to only provide NPWT to a portion ofthe patient's foot. Specifically, the area sealed may only be a heelportion of the foot or some portion of the bottom of the foot largerthan just the heal portion but smaller that the entire bottom of thefoot.

The operation of the treatment system 200 is similar to that oftreatment system 100 as described above. After a seal is created, thepatient would insert the foot into footwear that is configured toreceive the treatment system 200. Upon the commencement of walking, thesecond chamber 208 would be repeatedly compressed by the foot pressingdown and create a low pressure environment within the first chamber 206.One of the advantages of the treatment system 200 would be the abilityto treat multiple DFUs on the bottom of a patient's foot while providinga high level of comfort along with ease of use to the patient. Treatmentsystem 200 may be configured to work with any footwear that includesremovable innersoles, thus allowing a patient to treat wounds on thebottom of the foot while still using footwear of their own choosing.

Now referring to FIG. 3, another schematic embodiment of a negativepressure wound treatment system 300 is depicted as configured to treat awound away from the foot of a patient. The treatment system 300 mayinclude all or some of the characteristics and features of the treatmentsystems 100, 200 depicted in FIGS. 1 and 2. Treatment system 300includes a bandage portion 306 and a negative pressure portion 308. Thenegative pressure portion 308 is in fluid communication with the bandageportion 306 through a first valve (not shown) and a flexible tube 320.The negative pressure portion 308 is also in fluid communication withthe surrounding environment through a second valve (not shown). It iscontemplated that the operation of treatment system 300 is similar tothe operations already described. The patient would place the bandageportion 306 over a wound located somewhere on the body, in FIG. 3 it isdepicted on a leg just below the knee. Then the negative pressureportion 308 would be placed under the foot. As the patient walks, thenegative pressure portion 308 would be cyclically compressed, thusforming a low pressure environment under the bandage portion 306 andover the wound. It is contemplated that the flexible tube enables thebandage portion 306 to be placed anywhere on the body that a wound islocated.

It is also contemplated that the negative pressure portion 308 may beconfigured in multiple ways. In some embodiments, the negative pressureportion may be configured to sit under a patient's foot within footwearof the patient's choosing. In other embodiments, the negative pressureportion 308 may be included in an innersole device or built into afootwear item. Further still, in other embodiments, the negativepressure portion 308 may be configured to be in fluid communication withmultiple bandage portions 306, wherein each bandage portion 306 islocated over a different wound on a different location of the body. Itis contemplated that the negative pressure portion 308 may be adhesivelyattached to the bottom of the patient's foot or a wrap may hold it inplace such that the patient is not required to wear footwear during use.

Turning now to FIG. 4, another schematic embodiment of a negativepressure wound treatment system 400 is depicted in a configuration tofit under the bottom of the foot of a patient. The treatment system 400includes a first chamber 406 and a second chamber 408. The first chamber406 includes a dressing portion 414 and a reservoir 416. The firstchamber 406 is in fluid communication with the second chamber 408through a first valve 418 and a tube 420. The second chamber 408 is influid communication with the surrounding environment through a secondvalve 428. The treatment system 400 may include all or some of thecharacteristics and features of the treatment systems 100, 200, 300depicted in FIGS. 1-3. The operation of the treatment system 400 issimilar to the systems 100, 200, 300 described above. The first chamber406 may be secured by adhesive to cover a wound on a portion of thepatient's foot. The second chamber 408 may be placed under anotherportion of the patient's foot. Upon walking, the patient will cyclicallyactuate the second chamber 408 as described in the embodiments above tocreate a low pressure environment in the first chamber 406.

With continued reference to FIG. 4, the treatment system 400 has theadvantage of being a compact device that will easily fit in the footwearof the patient while providing NPWT to a wound on the bottom of apatient's foot. The first chamber 406 may be sized small enough to onlycover an area slightly larger than a single wound. In some embodiments,the first chamber 406 may be sized to cover a larger area to providetreatment to several wounds at the same time. Further, the secondchamber 408 may be placed under the portion of the foot to providemaximum comfort based on the individual preferences of the patient.

Turning now to FIG. 5, a schematic embodiment of a negative pressurewound treatment system 500 is depicted as a single device configured asa single bandage. The treatment system 500 includes a first chamber 506and a second chamber 508. The first chamber 506 includes a dressingportion 514 that is in contact with a wound and a reservoir 516. Thefirst chamber 506 is in fluid communication with the second chamber 508through a first valve 518. The second chamber 508 is in fluidcommunication with the surrounding environment through a second valve528. An outer cover 532 contains all of the components and aids thepatient or healthcare provider in applying the treatment system 500 andhelps retain the treatment system 500 to the patient's foot. Thetreatment system 500 may include all or some of the characteristics andfeatures of the treatment systems 100, 200, 300, 400 depicted in FIGS.1-4. The operation of the treatment system 500 is similar to the systems100, 200, 300, 400 as described above. The patient attaches thetreatment system 500 such that the first chamber 506 is over a wound andthe dressing portion 514 is in contact with the wound. The first chamber506 may be secured with adhesive and forms a seal around the wound. Theouter cover 532 may also be secured with adhesive to retain thetreatment system 500 in place similar to a self-adhesive bandage. As thepatient walks, the second chamber 508 is cyclically compressed. It iscontemplated that the treatment system 500 may be placed to treat awound located anywhere on the foot such that the second chamber 508 isactuated appropriately during walking. While the treatment system 500 isdepicted placed under the front part of the foot, other portions (e.g.,the arch, the heal, a toe) would also be acceptable as long as the firstchamber 506 can create a seal around the wound and the second chamber508 is actuated by the walking motion of the patient. It is alsocontemplated that the treatment system 500 may be sized to treatdifferent sized wounds on different parts of the foot depending on thesize and severity of the wound.

Turning now to FIG. 6, a flow chart depicting a NPWT process 600 forutilizing any of the treatment systems 100, 200, 300, 400, 500 to treata patient with a DFU. The process starts out with a DFU patient 610 thatneeds treatment. The healthcare provider must determine if the DFUpatient 610 is eligible for treatment with the one of the treatmentsystems 100, 200, 300, 400, 500 by deciding in block 620 if the patientcan walk and if the patient meets any and all other criteria. If thepatient is not eligible the healthcare provider may suggest alternativetreatment in block 630. Should the healthcare provider determine thepatient is eligible; the next step is to prescribe the treatment anddevice for X days in block 640. At this time the healthcare provider mayapply the treatment system selected to the wound or give the treatmentsystem selected to the DFU patient 610 for application later. It iscontemplated that X days could be any of the values or ranges previouslymentioned including from a few hours to a few weeks. Next, the DFUpatient 610 is examined by the healthcare provider in block 650. Thehealthcare provide then must determine in block 660 if there are anyunexpected complications. If there are complications, the healthcareprovider may reevaluate the DFU patient in block 620 for eligibility tobe treated with any of the treatment systems 100, 200, 300, 400, 500 andcontinue the process accordingly. If the healthcare provide does notidentify any complications, a decision to continue treatment is made inblock 670. If the patient does not require further treatment, thetreatment is ended in block 690. However, if further treatment isrequired, the healthcare provider may replace the entire treatmentsystem 100, 200, 300, 400, 500 or only a relevant portion in block 680.The process then moves back to assigning the X length of time fromtreatment in block 640 and repeats as described above.

FIG. 7 depicts a flowchart of a NPWT process 700 similar to the process600 except the treatment system 100, 200, 300, 400, 500 includes atleast one sensor 150 and/or an external device 155. The process 700starts out with a DFU patient 710 that needs treatment. The healthcareprovider must determine if the DFU patient 710 is eligible for treatmentwith the one of the treatment systems 100, 200, 300, 400, 500 bydeciding in block 720 if the patient can walk and if the patient meetsany and/or all other criteria. If the patient is not eligible, thehealthcare provide may suggest alternative treatment in block 730.Should the healthcare provider determine the patient is eligible; thenext step is to apply appropriate treatment system and determine if thesensor 150 is showing that the DFU patient 710 is walking in block 732.The process continues on to block 736 where the healthcare providerverifies that the sensor is measuring a low pressure from the walkingaction of the DFU patient. If during the process of blocks 732 and 736the healthcare provide determines that the treatment system is notperforming, the healthcare provider may change out the treatment systemor reposition the treatment system. The process proceeds once it isdetermined that the treatment system is operating correctly to block 740where the healthcare provider prescribes the treatment for X days. Thenext block 750 is the examination of the DFU patient 710 by thehealthcare provider after the treatment time period X has elapsed. Thehealthcare provider then must determine in block 760 if there are anyunexpected complications. If there are complications, the healthcareprovider may move back in the process to block 720 to reevaluate the DFUfor eligibility to be treated with any of the treatment systems 100,200, 300, 400, 500 and continue the process accordingly. If thehealthcare provide does not identify any complications, a decision tocontinue treatment is made in block 770. If the patient does not requirefurther treatment, the treatment is ended in block 790. However, iffurther treatment is required, the healthcare provider may replace theentire treatment system or only a relevant portion in block 780. Theprocess then moves back to assigning the X length of time from treatmentin block 740 and repeats as described above.

It is contemplated that one or more aspects of the treatment system 500provide unique advantages to a patient. Walking while wearing thetreatment system 500 is easy and comfortable because of the small size.Further, the ability to only treat a single wound as opposed to theentire foot or lower leg is a significant improvement over the priorart. Treatment system 500 requires no special footwear and is easilyapplied by the user over a wound. The comfort and quality of lifeimprovements provided by a patient being able to easily treat a woundlocated on the bottom surface of a foot is a significant advantage thatshould lead to better and faster healing.

In a different embodiment, any of the systems described herein may beapplied wherein no wound is present to locally induce or mimic thetherapeutic effects of massage.

Any of the embodiments described herein may be modified to include anyof the structures or methodologies disclosed in connection withdifferent embodiments. Further, the present disclosure is not limited tonegative pressure wound treatment systems of the type specificallyshown.

A negative pressure wound treatment system is presented that providesnegative pressure wound therapy to a wound. Thus, a user may experiencethe benefit provided of improved quality of life as the wound healswhile the treatment system helps prevent infection and increases bloodflow to the area of the wound.

In a different embodiment, a negative pressure treatment system ispresented wherein a wound or ulcer is present or not, to treatconditions as seroma plantar fasciitis, foot pain including formcirculatory problems, lymphedema and neurogenic origins as footneuropathy.

Numerous modifications to the present invention will be apparent tothose skilled in the art in view of the foregoing description.Accordingly, this description is to be construed as illustrative onlyand is presented for the purpose of enabling those skilled in the art tomake and use the invention and to teach the best mode of carrying outsame. The exclusive rights to all modifications which come within thescope of the appended claims are reserved.

I/We claim:
 1. A wound treatment device comprising: a first chamberconfigured to sealingly engage a portion of a subject; a second chamberfluidly coupled to the first chamber; a valve fluidly coupled to thefirst chamber and the second chamber; wherein at least the secondchamber forms part of an insole that is configured to be positionedwithin footwear, the second chamber being configured to be actuated bythe subject while walking; and wherein when the second chamber isactuated, fluid from the first chamber is directed through the valve andinto the second chamber to create a negative pressure environment withinthe first chamber.
 2. The wound treatment device of claim 1, wherein thevalve is a first valve and further comprising a second valve fluidlycoupled to the second chamber and the ambient environment; and whereinwhen the second chamber is actuated, fluid from the second chamber isdirected through the second valve and out into the ambient environment.3. The wound treatment device of claim 2, wherein the insole includesthe first chamber, the first valve, and the second valve.
 4. The woundtreatment device of claim 3, wherein the first chamber is configured tocontact a heel of a foot of the subject; and wherein the second chamberis configured to contact an arch of the foot of the subject.
 5. Thewound treatment device of claim 1, further comprising an adhesiveconfigured to seal the first chamber to the portion of the subject. 6.The wound treatment device of claim 1, further comprising a tube that isfluidly coupled to the first chamber and the second chamber.
 7. Thewound treatment device of claim 1, further comprising an absorbentmaterial positioned within the second chamber; and wherein liquid fromthe first chamber is directed through the valve, into the secondchamber, and absorbed by the absorbent material.
 8. The wound treatmentdevice of claim 1, further comprising an absorbent material positionedwithin the first chamber, the absorbent material being configured toabsorb liquid that is within the first chamber.
 9. The wound treatmentdevice of claim 1, wherein the portion of the subject is a bottom of afoot of the subject that includes a wound; and wherein when the firstchamber sealingly engages the portion of the subject, the first chamberencloses the wound.
 10. The wound treatment device of claim 1, whereinthe valve includes a release mechanism that is actuatable, and whereinwhen the release mechanism is actuated, the negative pressureenvironment created in the first chamber is removed.
 11. The woundtreatment device of claim 1, further comprising a pressure sensorpositioned within the first chamber.
 12. A wound treatment devicecomprising: a first chamber configured to sealingly engage a bottom of afoot of a subject that includes a wound so that the first chamberencloses the wound, the first chamber including an adhesive to seal thefirst chamber to the bottom of the foot of the subject; a second chamberfluidly coupled to the first chamber; a valve fluidly coupled to thefirst chamber and the second chamber; wherein the first chamber and thesecond chamber are configured to be positioned within footwear, thesecond chamber being configured to be positioned below the foot of thesubject and actuated by the subject while walking; wherein when thesecond chamber is actuated, fluid from the first chamber is directedthrough the valve and into the second chamber to create a negativepressure environment within the first chamber.
 13. The wound treatmentdevice of claim 12, further comprising an insole that includes the firstchamber, the second chamber, and the valve; and wherein the insole isconfigured to be positioned within the footwear of the subject.
 14. Thewound treatment device of claim 12, wherein the valve is a first valveand further comprising a second valve fluidly coupled to the secondchamber and the ambient environment; and wherein when the second chamberis actuated, fluid from the second chamber is directed through thesecond valve and out into the ambient environment.
 15. The woundtreatment device of claim 12, further comprising an absorbent materialpositioned within the second chamber; and wherein liquid from the woundis directed into the first chamber, through the valve, and into thesecond chamber, in which the liquid is absorbed by the absorbentmaterial.
 16. The wound treatment device of claim 12, wherein the valveincludes a release mechanism that is actuatable, and wherein when therelease mechanism is actuated, the negative pressure environment createdin the first chamber is removed.
 17. The wound treatment device of claim12, further comprising a pressure sensor positioned within the firstchamber.
 18. A method of treating a wound, the method comprising:positioning an insole into footwear of a subject, the insole including afirst chamber, a second chamber, and a valve, the first chamber beingfluidly coupled to the second chamber, and the valve being fluidlycoupled to the first chamber and the second chamber; positioning thefirst chamber over a wound a subject so that the first chamber enclosesthe wound; positioning the second chamber below a foot of the subjectthat is secured by the footwear; actuating the second chamber whilewalking thereby directing fluid from the first chamber, through thevalve, and into the second chamber to create a negative pressureenvironment within the first chamber.
 19. The method of claim 18,wherein the insole includes a second valve fluidly coupled to the secondchamber and the ambient environment; and wherein when the second chamberis actuated, fluid from the second chamber is directed through thesecond valve and out into the ambient environment.
 20. The method ofclaim 18, wherein the valve includes a release mechanism that isactuatable, and further comprising actuating the release mechanism toremove the negative pressure environment in the first chamber.